(84 days)
The IMMIX™ Thin Film is to be used wherever temporary wound support is required, to reinforce soft tissue where weakness exists, or for the repair of hernia or other fascial defects that require the addition of a reinforcing, or bridging material to obtain the desired surgical result. This includes, but is not limited to the following procedures: vaginal prolapse repair, colon and rectal prolapse repair, reconstruction of the pelvic floor and sacral colposuspension.
The IMMIX™ Thin Film is manufactured using poly(D,L-lactide-coglycolide) polymer and will be provided in sheets of 10 mm to 120 mm x 120mm. Other shapes and sizes will be provided as needed for particular surgical procedures. Additionally, the device can be cut with scissors to obtain desired shapes and sizes.
The thickness of the IMMX™ Thin Film will range from 50 to 300 microns, according to the region to be treated, and will be provided with and without macroporous holes. The holes will range from 100 microns to 1000 microns in diameter. The holes may be aligned, offset, or random patterns. The borders of the sheets may be aligned with the holes to attach suture material.
The provided document describes a medical device called IMMIX™ Thin Film (K024199), a polymeric surgical mesh. This 510(k) summary focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and performance metrics for a novel AI/software device. Therefore, many of the requested data points (related to AI performance, sample sizes for AI training/testing, expert ground truth, MRMC studies, etc.) are not applicable to this submission.
However, I can extract the relevant information regarding the device's performance as presented in the submission.
1. Table of acceptance criteria and the reported device performance
The submission does not explicitly state quantitative "acceptance criteria" in the way one might for a diagnostic AI device (e.g., target specificity, sensitivity). Instead, the performance is demonstrated through studies showing the physical and biocompatible properties of the material, and its equivalence to a predicate device. The implicit acceptance criteria are that the device is biocompatible, biodegradable, and strong enough for its intended use, performing comparably to an already cleared device.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Biocompatibility | Biocompatibility assessment performed by an independent certified laboratory demonstrated the biocompatibility of the materials used for this device. |
| Degradation/Resorbability | Degradation testing performed in a physiological buffered saline solution at 37 ℃ showed that the device is fully resorbable over a period of months. |
| Mechanical Strength (Suture Pullout) | OsteoBiologics performed suture pullout testing on a family of thin film products, which are identical in material composition. The results demonstrated that the films could withstand substantial loads and deformations before its physical integrity is compromised, therefore supporting the suitability of the IMMIX™ Thin Film for use in a clinical situation. |
| Substantial Equivalence to Predicate Device (MacroPore Surgi-Wrap (TS), K012025) | The IMMIX™ Thin Film is substantially equivalent in design, function and intended use to the MacroPore Surgi-Wrap (TS), cleared as K012025 on December 3, 2001. |
2. Sample size used for the test set and the data provenance
The document does not specify a "test set" in the context of an algorithm's performance. The studies mentioned are laboratory tests:
- Biocompatibility: No sample size specified, likely performed on material samples according to standard protocols for medical devices.
- Degradation testing: No sample size specified, likely performed on material samples.
- Suture pullout testing: Performed on "a family of thin film products," but specific sample sizes are not provided.
- Data Provenance: The studies were performed by OsteoBiologics (suture pullout, degradation) and an "independent certified laboratory" (biocompatibility). The origin of this data is therefore in-house/contracted lab testing, not human patient data, and it's inherently prospective (experimental testing).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is a physical surgical mesh, not a diagnostic or AI-driven device requiring expert ground truth for a test set.
4. Adjudication method for the test set
Not applicable for the reasons stated above.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a physical medical device, not an AI or diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device.
7. The type of ground truth used
For the laboratory tests:
- Biocompatibility: Ground truth is established by standard biological assays and observation of cellular responses, as interpreted by expert toxicologists/biocompatibility specialists.
- Degradation: Ground truth is a direct measurement of material degradation over time under controlled conditions.
- Suture Pullout Testing: Ground truth is the direct measurement of force and deformation until failure using standardized mechanical testing equipment.
8. The sample size for the training set
Not applicable. There is no AI algorithm involved, and thus no "training set" in this context.
9. How the ground truth for the training set was established
Not applicable. There is no AI algorithm involved, and thus no "training set."
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MAR 1 4 2003
510(k) SUMMARY
| Submitter | Contact |
|---|---|
| OsteoBiologics, Inc. | Gabriele G. Niederauer, Ph.D. |
| 12500 Network, Suite 112 | Director of Research and Development |
| San Antonio, Texas 78249 | Phone: 210-690-2131 (ext. 228) |
| USA | Fax: 210-690-2559 |
| E-mail: gabi@obi.com |
| Date of Summary: | December 19, 2002 |
|---|---|
| Common Name: | Polymeric Surgical Mesh |
| Proprietary Name: | IMMIX™ Thin Film |
| Device Classification: | Polymeric surgical mesh (Product Code 79FTL) is a Class Iprosthetic device, per 21 CFR §878.3300 |
| 510(k) Number: | K024199 |
Description of Device: The IMMIX™ Thin Film is manufactured using poly(D,L-lactide-coglycolide) polymer and will be provided in sheets of 10 mm to 120 mm x 120mm. Other shapes and sizes will be provided as needed for particular surgical procedures. Additionally, the device can be cut with scissors to obtain desired shapes and sizes.
The thickness of the IMMX™ Thin Film will range from 50 to 300 microns, according to the region to be treated, and will be provided with and without macroporous holes. The holes will range from 100 microns to 1000 microns in diameter. The holes may be aligned, offset, or random patterns. The borders of the sheets may be aligned with the holes to attach suture material.
Intended Use: The IMMIX™ Thin Film is to be used wherever temporary wound support is required, to reinforce soft tissue where weakness exists, or for the repair of hernia or other fascial defects that require the addition of a reinforcing, or bridging material to obtain the desired surgical result. This includes, but is not limited to the following procedures: vaginal prolapse repair, colon and rectal prolapse repair, reconstruction of the pelvic floor and sacral colposuspension.
Substantial Equivalence: The IMMIX™ Thin Film is substantially equivalent in design, function and intended use to the MacroPore Surgi-Wrap (TS), cleared as K012025 on December 3, 2001.
Biocompatibility assessment performed by an independent certified laboratory Testing: demonstrated the biocompatibility of the materials used for this device. Degradation testing performed in a physiological buffered saline solution at 37 ℃ showed that the device is fully resorbable over a period of months. OsteoBiologics performed suture pullout testing on a family of thin film products, which are identical in material composition. The results demonstrated that the films could withstand substantial loads and deformations before its physical integrity is compromised, therefore supporting the suitability of the IMMIX™ Thin Film for use in a clinical situation.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of human figures.
MAR 1 4 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OsteoBiologics, Inc. Gabriele G. Niederauer, Ph.D. Director of Research and Development University Business Park 12500 Network, Suite 112 San Antonio. Texas 78249-3308
Re: K024199
Trade/Device Name: IMMIX™ Thin Film, Models: PSS-004-S, PSS-004-SP, PSS-004-M Regulation Number: 878.3300 Regulation Name: Polymeric surgical mesh Regulatory Class: Class II Product Code: FTL Dated: December 19, 2002 Received: December 20, 2002
Dear Dr. Niederauer:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing
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Page 2 - Dr. Gabriele G. Niederauer
(21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address
http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Muriam C. Provost
tol Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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| INDICATIONS FOR USE | |
|---|---|
| 510(k) Number (if known): | K024199 |
| Device Name: | IMMIX™ Thin Film |
| Indications For Use: | The IMMIX™ Thin Film is to be used wherever temporary wound support is required, to reinforce soft tissue where weakness exists, or for the repair of hernia or other fascial defects that require the addition of a reinforcing, or bridging material to obtain the desired surgical result. This includes, but is not limited to the following procedures: vaginal prolapse repair, colon and rectal prolapse repair, reconstruction of the pelvic floor and sacral colposuspension. |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Miriam C. Provost
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices
| 510(k) Number | K024199 |
|---|---|
| Prescription Use(Per 21 CFR 801.109) | OR Over-The-Counter Use |
:
§ 878.3300 Surgical mesh.
(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.